- Consolidate data and disparate global systems and spreadsheets
- Enable automated submission of XEVMPD data to the EMA
- Create an integrated RIM solution and deploy globally
- Develop best practices to achieve a single source of truth for regulatory information
- Deliver first-of-kind Tracker embedded with XEVMPD tool for automated submission
- Achieve first stage in integrated RIM capabilities
- Maintained compliance with global regulatory requirements
- Enabled effective planning, tracking and reporting of regulatory applications
- Enabled quick decision making with accurate and consistent data
An Integrated Approach
As part of a network of independent associated companies with global reach, Mundipharma Research is challenged with dispersed and inconsistent data. While the company had a central database, each of the independent associated companies replicated the data within their own spreadsheets, which created inconsistent and incomplete data.
Mundipharma Research wanted to consolidate information through a globally accessed but centrally managed RIM solution. Its goal was to achieve a single source of truth for all registration information across the global value chain and product lifecycle to meet both compliance and commercial objectives.
A Collaborative Journey
Mundipharma Research and CSC have a strong and enduring relationship dating back more than 10 years, during which time Mundipharma Research has deployed many CSC products, including FirstDoc and the TRS publishing suite. That established business relationship led Mundipharma Research to turn to CSC for an integrated RIM solution.
“It’s very much a collaborative relationship where we work closely with CSC as a team to bounce ideas off one another in order to reach the same goals, which are systems integration and achieving return on investment,” says Jon Sanford, Mundipharma Research’s head of regulatory information management and operations.
Leading the Way
One of the key elements of the RIM project was the delivery of CSC’s unique XEVMPD module, which was developed during a highly collaborative process in which CSC enhanced and modified the solution in line with feedback from Mundipharma Research. The result is a first-of-kind product built on industry best practices — a product that Mundipharma Research was the first company to use.